Global Regulatory Affairs Director - Devices & Drug-Device
$238k - $374kDormont Manufacturing Co
Takeda is seeking an Executive Director for Global Regulatory Affairs in Boston, MA. This role will provide strategic leadership on regulatory affairs for medical devices and drug-device combination products, ensuring compliance and timely approvals. The ideal candidate must possess an advanced degree, over 20 years of experience in the industry, and a strong background in regulatory submissions. This position offers an attractive salary range of $238,000 - $374,000 and comprehensive benefits. #J-18808-Ljbffr Dormont Manufacturing Co
$238k - $374k
...boundaries of what is possible in order to bring life‑changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination Product, you will provide strategic leadership and development to global regulatory...SuggestedTemporary workWork at officeLocal areaRemote workWorldwide$238k - $374k
JobRx, Inc. is seeking an Executive Director of Global Regulatory Affairs in Boston, MA. This leadership role requires over 20 years of industry experience... ...expertise in regulatory submissions for medical devices and combination products. You will oversee a team to develop...Suggested- A global health innovation company is seeking an Executive Director for Global Regulatory Affairs to lead strategic initiatives for medical devices and drug-device combination products. The role requires over 20 years of industry experience with significant expertise in...SuggestedWorldwide
- Responsibilities Lead development and implementation of regulatory strategies for pure device and drug-device combination products with a focus on Human... ...opinion leader and foundational subject matter expert for global Human Factors regulation for devices/combination...SuggestedNight shift
$212k - $333.19k
...changing therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you will... ...driving prospective and proactive implementation. Globally influence and serve as a key opinion leader and resource...SuggestedMinimum wageFull timeTemporary workLocal areaWorldwideNight shift- ...seeking a seasoned leader to define and execute the strategy for drug-device combination product development. The role involves managing... ...industry. Successful candidates will demonstrate a strong regulatory background and proven experience in leading complex technical...
$99k - $232k
...risk and compliance focus on maintaining regulatory compliance and managing risks for... ...services to pharmaceutical and medical device clients Supervise, develop, and coach teams... ...client relationships Specialization in global compliance program strategy and design...- Partner closely with the Director of Regulatory Affairs to define and implement regulatory strategies for... ...lifecycle management of Class II medical devices. Provide regulatory guidance during... ...(RAC). Experience supporting global regulatory submissions (e.g., EU MDR,...
$154.4k - $242.55k
...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team... ...CMC requirements relevant to global drug development and post-market support. Proven...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...Executive Director, Global Regulatory Affairs Cmc Early Development Are you looking for a patient-focused company that will inspire... ...functions (process development, analytical, formulation, drug substance/drug product, device/combination where applicable, quality, clinical,...
- ...Job Description As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic leadership and development... ...(process development, analytical, formulation, drug substance/drug product, device/combination where applicable, quality, clinical,...Temporary workLocal area
$270k - $330k
...Senior Director, Global Regulatory Affairs, Oncology Ipsen is a mid-sized global biopharmaceutical company... ...incl PIP, scientific advice, orphan drug designation submissions. Advocate... ...preferred): ~ Knowledge of medical device / drug device combination regulations...Temporary workLocal areaWorldwideFlexible hours- ...A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...
- ...Cardinal Health is looking for a Sr Regulatory Affairs Specialist to join their Medical Solutions Regulatory Affairs team. This remote position... ...regulatory compliance across a diverse portfolio of medical devices, including new product development and change assessment....Remote work
$137k - $215.27k
...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team... ...regulatory CMC requirements relevant to global drug development and post‑market support. Proven...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$188k - $258.5k
...development, and usability of drug delivery systems, with a strong... ...human factors integration and regulatory readiness. Roles and... ...partners. Facilitate alignment of device strategy across multiple programs... ...development. Familiarity with global regulatory frameworks for medical...Temporary work$102.48k - $163.97k
..., ensuring their accuracy and regulatory compliance throughout the software... ...pre- and post-market medical device software. Conducts detailed... ...submission of documentation for global registrations to enable timely... .../Vets and maintains a drug-free workplace. #J-18808-Ljbffr...Full timeWork at officeImmediate startWork visaRelocation package3 days per week- ...professionals for a part-time opportunity focused on providing feedback for an AI-powered platform that aids in medical device risk management and regulatory compliance. You will test new features, review documentation workflows, and influence product development based on...Remote jobPart timeFlexible hours
$147k - $212k
...Job Title: GRA Device Lead (Associate Director) Location: Cambridge, MA/ Morristown, NJ About... ...medicine? The race is on to speed up drug discovery and development to find... ...teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally...Temporary workLocal areaWorldwideFlexible hours$157.2k - $256.6k
...Associate Director, Global CMC Regulatory Strategy As an Associate Director you will... ..., mentor CMC Regulatory Affairs (RA) staff, supporting cross... ...licensure, and marketing of drugs and/or biologics. Lead and... .... Experience with device regulatory requirements and...Work at officeRemote workWorldwideRelocation package3 days per week- ...requires expertise in quality systems, complaint management, and regulatory compliance. The ideal candidate will possess a Bachelor's... ...at least 5 years of experience in the pharmaceutical or medical device industry. This position offers an opportunity to impact product...
$137k - $215.27k
Initial Therapeutics, Inc. is looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device experience and a BS/BA degree in a scientific discipline. Responsibilities include executing regulatory...- Makro Scientific is seeking an experienced professional to join their Global Regulatory Affairs team. The role involves planning, writing, and compiling regulatory reports such as DSURs and NDA annual reports, as well as contributing to product regulatory strategy documents...
- ...Description JOB TITLE: Executive Director, Global Regulatory Affairs DEPARTMENT: Regulatory Affairs... ...regulatory expertise in oncology drug and biologic development, strong leadership... ...diagnostics (CDx), biomarkers, devices, and combination products, ensuring...
$160.5k
...YouTube, LinkedIn and Tik Tok ( . Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is... ...of the product. Demonstrates strong understanding of drug development and leadership behaviors consistent with level...Temporary workLocal areaWorldwide$196.7k - $353.4k
...is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader... ...broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license...Permanent employmentWork at officeWork from home$210k - $270k
...Nova Biomedical: One Global Brand. One Vision. Together under... ...Oversees and leads the Regulatory Affairs function to ensure global regulatory... ...2017/746 (IVDR); UK Medical Devices Regulations 2002 (UK MDR 200... ...over 100 countries to speed drug development and enhance...Hourly payWork at officeLocal areaFlexible hours- ...Proven Scientific Placement is seeking a Global Product Monitoring Vigilance Report... ...maintaining best practices to meet customer and regulatory requirements. The ideal candidate will... ...'s degree and experience in medical device reporting are required. #J-18808-Ljbffr...
- ...AstraZeneca is seeking a Senior Regulatory Affairs Director in Boston, MA to lead global regulatory strategy for oncology programs. The role involves overseeing... ...advanced degree in a relevant field, proven regulatory drug development experience, and demonstrated leadership...Work at officeRemote work
$154.4k - $242.55k
...Defines, develops and leads global strategies to maximize global regulatory success towards... ...Accountabilities: The Associate Director will be responsible for... ...Solid working knowledge of drug development process and... ...concepts within regulatory affairs and implications across...Minimum wageTemporary workLocal areaRemote work
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